Ophthalmology Division, Rabin Medical Center-Beilinson Hospital, Petach Tikva, Israel.
Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Eye (Lond). 2023 Aug;37(12):2482-2487. doi: 10.1038/s41433-022-02358-y. Epub 2023 Jan 23.
To evaluate the effectiveness of cemiplimab, a Programmed-cell-death-1(PD-1) protein inhibitor, for the treatment of cutaneous periocular-locally-advanced squamous-cell-carcinoma (POLA-SCC) with orbital-invasion.
Multicentre real-world retrospective study. Demographic and clinical data were collected and analysed for patients with biopsy-proven POLA-SCC(AJCC-T4) with orbital-invasion who were treated with cemiplimab at one of four tertiary medical centres in 2019-2022.
The cohort included 13 patients, 8 males and 5 females, of median age 76 years (IQR65-86). The median duration of treatment was 5.0months (IQR3.5-10.5) and the median follow-up time, 15.0 months (IQR10.5-30). The overall response rate was 69.2%. Complete response was documented in seven patients (53.8%), partial response in two (15.4%), stable disease in one (7.7%), and progressive disease in two (15.4%); in one patient (7.7%), response was not evaluable. Six complete responders (46.1% of the cohort) received no further treatment and did not have a recurrence during an average follow-up of 6.14 (±6.9) months from treatment cessation. None of the patients underwent orbital-exenteration. The majority of adverse events were mild (grade-1), except for a moderate increase in creatinine level (grade-2), severe bullous dermatitis (grade-3), and myocarditis (grade-5) in one patient each. Four patients (30.7%) died during the follow-up period, all of whom had an Eastern-Cooperative-Oncology-Group score of 4 at presentation.
To our knowledge, this is the largest study to date on cemiplimab therapy for cutaneous POLA-SCC with orbital-invasion. Treatment was shown to be effective, with an overall response rate of 69.2%. Cemiplimab holds promise for the treatment of patients with tumours invading the orbit as it may alleviate the need for orbital exenteration.
评估 PD-1 蛋白抑制剂西米普利单抗治疗伴眼眶侵犯的皮肤眶周局部晚期鳞状细胞癌（POLA-SCC）的疗效。
多中心真实世界回顾性研究。收集并分析了 2019 年至 2022 年在四家三级医疗中心接受西米普利单抗治疗的经活检证实为伴眼眶侵犯的 AJCC-T4 期 POLA-SCC 患者的人口统计学和临床数据。
该队列包括 13 名患者，8 名男性和 5 名女性，中位年龄为 76 岁（IQR65-86）。中位治疗持续时间为 5.0 个月（IQR3.5-10.5），中位随访时间为 15.0 个月（IQR10.5-30）。总缓解率为 69.2%。7 名患者（53.8%）完全缓解，2 名患者（15.4%）部分缓解，1 名患者（7.7%）疾病稳定，2 名患者（15.4%）疾病进展，1 名患者（7.7%）缓解不可评估。6 名完全缓解者（队列的 46.1%）未接受进一步治疗，在停止治疗后平均随访 6.14（±6.9）个月时未复发。无患者行眼眶内容剜除术。大多数不良事件为轻度（1 级），仅 1 名患者出现中度肌酐水平升高（2 级）、严重大疱性皮炎（3 级）和心肌炎（5 级）各 1 例。4 名患者（30.7%）在随访期间死亡，均为就诊时 ECOG 评分 4 分。
据我们所知，这是迄今为止关于西米普利单抗治疗伴眼眶侵犯的皮肤 POLA-SCC 的最大研究。结果显示治疗有效，总缓解率为 69.2%。西米普利单抗有望用于治疗侵犯眼眶的肿瘤患者，因为它可能减轻行眼眶内容剜除术的需求。
